RFI - Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract seeks information on the development and availability of influenza vaccines that can provide immediate, partial protection at the onset of a pandemic, referred to as "Day One vaccines." These vaccines aim to bridge the critical protection gap that currently exists due to the time lag—typically three months—between identifying a novel pandemic influenza strain and the deployment of strain-matched vaccines. Specifically, the focus is on vaccines that offer standard seasonal flu protection while also delivering some level of immunity against emerging pandemic influenza viruses, thereby reducing disease spread and severity during the early stages of a pandemic response. The Department of Health and Human Services, through BARDA, is soliciting responses to better understand the maturity, technical feasibility, manufacturing readiness, and regulatory pathways of such dual-benefit vaccine candidates. Modeling suggests that even vaccines with modest efficacy can significantly reduce infection rates, delay peak outbreaks, and lower hospitalization risks by about 35%. The solicitation is categorized as a sources-sought notice and is open until mid-July 2026, with the work centered in Washington, D.C. The effort underscores a strategic public health priority to enhance pandemic preparedness by accelerating early vaccination coverage before strain-specific vaccines become available.
General Info
Agency
NAICS
Place of Performance
Washington, DC, 20024, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
“Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage”
Request for Information (RFI)
1.0 Background
Influenza viruses remain a persistent and evolving threat to public health in the United States and globally. Seasonal influenza epidemics cause significant morbidity and mortality each year, while novel zoonotic influenza subtypes retain the potential to trigger pandemics. A critical vulnerability in current pandemic preparedness is the time required—typically at least three months—between identification of a novel pandemic strain and deployment of strain-matched vaccines at scale.
The Center for the Biomedical Advanced Research and Development Authority (BARDA) has led efforts to develop improved influenza vaccines and expand domestic manufacturing capacity, including initiatives to accelerate vaccine development timelines. However, limitations in current vaccine technologies result in a protection gap during the earliest phase of a pandemic.
In a pandemic setting, early intervention is crucial to dampening the spread and impact of a novel virus. Prior modeling studies have demonstrated that a modestly effective but rapidly distributed vaccine can provide a greater benefit than a highly efficacious but delayed vaccine. Similarly, bolstering population immunity before a pandemic would lessen the damage caused by emergent influenza strains, even if the vaccine is only partially protective. BARDA refers to these vaccines as offering “Protection Before Day One”, with “Day One vaccines” providing some degree of protection at the outset of a pandemic. Day One vaccines, would:
- Deliver seasonal influenza protection; and
- Provide partial protection against emerging pandemic influenza viruses at the onset of a Public Health Emergency.
Modeling suggests that Day One vaccines can not only reduce the total number of infections and peak infection rate but also delay the peak to allow more time for strain-matched pandemic vaccines to become available. In addition to the population-level benefits, Day One vaccines would also benefit individual vaccine recipients by reducing the risk of severe disease. Even with modest effectiveness, receiving a Day One vaccine could reduce an individual’s hospitalization risk by 35%.
Through this RFI, BARDA seeks to understand the availability of candidate Day One vaccines, including their development maturity, technical feasibility, manufacturing readiness, and regulatory considerations associated with vaccine candidates intended to meet this dual-benefit profile.
Please see full Request for Information attached.